UK’s NICE calls for more info on Sanofi’s Lemtrada in draft guidance

UK drugs watchdog the National Institute for Health and Care Excellence (NICE) is calling on Genzyme, the biotech subsidiary of French drug major Sanofi (Euronext; SAN), to provide more information on its multiple sclerosis drug Lemtrada (alemtuzumab).

In draft guidance published for consultation, the NICE has requested a series of clarifications on the evidence submitted by the manufacturer. This draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS. Lemtrada, which Genzyme believes could generate peal sales of $3.5 billion, was recently approved for marketing in Europe and last month received a favorable opinion from a US Food and Drug Administration Advisory panel (The Pharma Letters September 17 and November 14).

Carole Longson, NICE Health Technology Evaluation Centre director, said: “When reviewing the evidence for alemtuzumab, the Appraisal Committee concluded that there were still questions to be answered. This is why we have requested more details from the manufacturer; to ensure that we have the information the Appraisal Committee needs to reach their conclusions.”

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